a multicenter trial of sprifermin (as902330 [recombinant human fibroblast growth factor-18]) or placebo after microfracture surgery for cartilage injury of the knee

Conditions: Cartilage Injury of Knee

Summary: this is a phase 2, double-blind, multicenter, randomized, placebo-controlled trial to evaluate the efficacy and safety of sprifermin (as902330) (recombinant human fibroblast growth factor-18 \[rhfgf-18\]) as an adjunct treatment to subjects following microfracture (mfx) surgery for cartilage injury of the knee. primary objectives * to evaluate the effect of sprifermin (as902330) intra-articular knee injections as adjunct to microfracture (mfx) surgery on the composition of the refilled cartilage in the target knee, as measured by gadolinium-enhanced magnetic resonance imaging (mri) of cartilage (dgemric) time constant 1 (t1) relaxation time at 6 months after mfx surgery * to evaluate the safety profile of sprifermin (as902330) when administered intra-articular into the knee as adjunct to mfx surgery in subjects with cartilage injury of the knee secondary objectives * to further support the efficacy and safety of sprifermin (as902330) as an adjunct to mfx for cartilage injury repair through symptomatic outcomes and quantitative mri measurement


Eligibility criteria:
inclusion criteria: * subjects with candidature for mfx surgery on the femoral articular surfaces (medial or lateral condyles or trochlear groove), with intact subchondral bone * subjects with moderate to severe pain in the target knee prior to surgery; average score greater than equal to (\>=) 4.0 over 7 consecutive days on numeric rating scale of pain intensity (completed within 30 \[+15\] days before surgery) * intraoperative inclusion criteria: subjects with 1 or 2 focal chondral lesions per target knee, where peripheral debridement to healthy cartilage results in all of the following: * each lesion has an area of \>= 1 square centimeter (cm\^2) and less than equal to (\<=) 4 cm\^2 * each lesion is \<= 6 millimeter (mm) in depth, as measured from the surrounding subchondral plate * arthroscopic confirmation that each non-osteochondritis dissecans (ocd) lesion is between international cartilage repair society (icrs) grades i and iii (d); a grade iii non-ocd lesion is equivalent to an outerbridge grade iv lesion with minimal subchondral bone loss * other protocol-defined inclusion criteria could apply exclusion criteria: * subjects with prior marrow stimulation treatment of the target knee, that is, mfx, micro-drilling, abrasion chondroplasty or cartilage repair including, but not limited to, autologous chondrocyte implantation (aci), matrix/membrane autologous chondrocyte implantation (maci), or osteochondral transplantation (autologous or allogeneic) * subjects with body mass index (bmi) of greater than 35 kilogram per square meter (kg/m\^2) at screening * malalignment of the target knee greater than 5 degrees as measured from the mechanical axis, as confirmed by alignment (long bone) x-ray images * subjects with clinical and/or radiographic disease diagnosis of the target knee joint including, but not limited to the following: generalized osteoarthritis (oa), rheumatoid arthritis, or avascular necrosis * subjects who have any contraindication to mri or gadolinium-based or iodinated contrast agents according to the site's standard practice guidelines * other protocol-defined exclusion criteria could apply

Keywords: microfracture surgery cartilage repair knee surgery